Etikem-1 (Etizolam Tablets I.P. 1 mg)

Etikem-1 (Etizolam Tablets I.P. 1 mg) — Clinical Overview, Uses, and Safety Information

Overview

Etikem-1 (Etizolam Tablets I.P. 1 mg), produced by NPB Pharmaceuticals, is a prescription medicine belonging to the thienodiazepine class — a group chemically related to benzodiazepines. Each tablet contains 1 mg of Etizolam, formulated according to Indian Pharmacopoeia (I.P.) standards.

Etizolam exerts anxiolytic, hypnotic, sedative, and muscle-relaxant actions by enhancing the natural calming neurotransmitter gamma-aminobutyric acid (GABA) in the brain. Clinically, it is used for the short-term management of anxiety, panic attacks, and insomnia related to stress or emotional tension.

When used responsibly under medical supervision, Etikem-1 helps reduce psychological and physical symptoms of anxiety, promotes relaxation, and improves sleep quality.

Pharmacological Profile

Category	Details
Therapeutic class	Anxiolytic / Hypnotic
Pharmacological class	Thienodiazepine derivative
Active ingredient	Etizolam 1 mg
Dosage form	Oral tablet
Manufacturer	NPB Pharmaceuticals
Pack size	10 × 10 tablets
Regulatory status	Schedule H prescription medicine (Rx Only)

Mechanism of Action

Etizolam acts on the GABA-A receptor complex, the same receptor family influenced by classical benzodiazepines. By binding to a specific allosteric site, Etizolam increases GABA’s affinity for its receptor. This interaction enhances chloride-ion influx into neurons, leading to hyperpolarization and a subsequent decrease in neuronal excitability.

Physiological outcomes

• Reduced cortical and limbic over-activity responsible for fear and anxiety.
• Diminished tension and panic reactions.
• Sedative and hypnotic effects facilitating sleep.
• Skeletal-muscle relaxation through central inhibition of polysynaptic pathways.

Therapeutic Indications

Etikem-1 (Etizolam Tablets I.P. 1 mg) is indicated for short-term symptomatic treatment of:

1. Generalized Anxiety Disorder (GAD)
   Persistent, excessive anxiety or worry that interferes with daily activities.
2. Panic Disorder
   Recurrent panic attacks characterized by palpitations, trembling, sweating, or feelings of impending doom.
3. Anxiety associated with Depression
   As adjunctive therapy where anxiety predominates.
4. Insomnia related to Anxiety or Stress
   Difficulty initiating or maintaining sleep due to mental over-activity.
5. Psychosomatic Tension and Muscle Spasm
   Useful in short-term relief of stress-related somatic symptoms.

Pharmacokinetics

Parameter	Characteristics
Absorption	Rapid oral absorption; bioavailability ≈ 90 %.
Onset of action	Within 30–60 minutes of ingestion.
Protein binding	~93 %.
Metabolism	Hepatic, mainly via CYP450 (especially CYP3A4).
Elimination half-life	6–8 hours (shorter than most benzodiazepines).
Excretion	Renal (metabolites).

The relatively short half-life minimizes next-day drowsiness, making Etizolam suitable for daytime anxiolytic use or nighttime administration for insomnia.

Dosage and Administration

Use only as prescribed by a qualified physician.
Dosage varies according to patient response, age, and clinical condition.

Typical adult dosage

• Anxiety disorders: 0.25 – 1 mg twice or thrice daily.
• Insomnia: 1 mg at bedtime.
• Maximum daily dose: generally not exceeding 3 mg.

Administration guidelines

• Take tablets orally with water, with or without food.
• Do not exceed the prescribed dose.
• Do not discontinue abruptly; taper gradually to prevent withdrawal symptoms.
• Use duration is usually not longer than 4 weeks unless clinically justified.

Target Audience

• Adults (≥ 18 years) diagnosed with anxiety, panic, or stress-related sleep disturbance.
• Patients requiring short-term pharmacologic relief of acute anxiety.
• Healthcare professionals managing anxiety-insomnia overlap disorders.
• Individuals under medical supervision seeking temporary stabilization before psychotherapy or lifestyle interventions.

Clinical Benefits of Etikem-1

1. Rapid Anxiolytic Effect – noticeable calming within an hour.
2. Improved Sleep Quality – restores normal sleep cycles by reducing hyperarousal.
3. Short Half-Life – minimizes daytime sedation and residual effects.
4. Muscle Relaxation – beneficial in stress-related tension headaches or spasms.
5. Fewer Cognitive Side-Effects than older benzodiazepines when used appropriately.
6. Ease of Titration – available 1 mg strength allows individualized dosing.
7. Manufactured under GMP for purity, consistency, and compliance with I.P. standards.

Contraindications

• Hypersensitivity to Etizolam or other benzodiazepine-class drugs.
• Myasthenia gravis (may aggravate muscle weakness).
• Severe hepatic or respiratory insufficiency.
• Acute narrow-angle glaucoma.
• Pregnancy and lactation (risk of fetal/neonatal CNS depression).

Warnings and Precautions

1. Dependence and Withdrawal
   • Prolonged or high-dose use may cause physical or psychological dependence.
   • Gradual tapering required when discontinuing.
2. Sedation and Impaired Alertness
   • Avoid driving, machinery operation, or tasks requiring focus.
3. Elderly Population
   • Increased sensitivity; use lowest effective dose (0.25 mg b.i.d.).
4. Concurrent CNS Depressants
   • Alcohol, opioids, or antihistamines potentiate sedative and respiratory-depressant effects.
5. Depression and Suicidality
   • Monitor closely if combined with antidepressants; Etizolam does not treat underlying depression.
6. Renal or Hepatic Impairment
   • Use with caution; adjust dose as needed.

Adverse Reactions

Common	Less Common	Rare/Serious
Drowsiness	Memory disturbance	Dependence/withdrawal
Dizziness	Blurred vision	Respiratory depression
Headache	Muscle weakness	Paradoxical excitement
Fatigue	Dry mouth	Allergic skin reaction

Most effects are mild and dose-related. Reducing the dose or adjusting timing often resolves symptoms.

Drug Interactions

• CYP3A4 Inhibitors (e.g., erythromycin, ketoconazole) ↑ Etizolam levels → enhanced sedation.
• CYP3A4 Inducers (e.g., carbamazepine, rifampicin) ↓ Etizolam concentration → reduced efficacy.
• Opioids and alcohol → additive CNS depression, respiratory risk.
• Antipsychotics or antidepressants → increased sedation; monitor carefully.

Always disclose current medications and supplements to the prescriber.

Overdose Management

Symptoms: profound sedation, ataxia, slurred speech, hypotension, respiratory depression.
Treatment:

• Maintain airway and cardiorespiratory function.
• Flumazenil, a benzodiazepine antagonist, may reverse effects under medical supervision.
• Continuous monitoring until recovery.

Use in Specific Populations

Population	Recommendation
Pregnancy	Avoid unless essential; may cause neonatal respiratory depression.
Lactation	Excreted in breast milk; avoid nursing.
Children	Safety and efficacy not established.
Elderly	Lower initial doses; monitor for confusion and falls.
Hepatic impairment	Dose reduction recommended.

Storage and Handling

• Store below 30 °C, protected from light and moisture.
• Keep in the original blister until use.
• Keep out of reach of children and pets.
• Dispose of unused medicine through approved take-back programs; do not flush into wastewater.

Patient Counselling Information

Healthcare professionals should advise patients to:

1. Follow the prescribed regimen exactly—never increase or skip doses.
2. Avoid alcohol and sedatives during therapy.
3. Report unusual mood or behavior changes promptly.
4. Taper gradually under medical guidance to prevent withdrawal.
5. Use non-pharmacologic strategies (stress management, sleep hygiene) alongside medication.
6. Secure the medication to prevent misuse or accidental ingestion.

Problem Addressed

Anxiety and stress-related insomnia are among the most common mental-health concerns worldwide. They manifest as restlessness, excessive worry, palpitations, and disturbed sleep, severely affecting productivity and emotional wellbeing.

For patients whose symptoms are not adequately controlled through counseling or lifestyle modification, short-term pharmacologic therapy is sometimes required. Etikem-1 (Etizolam 1 mg) provides medical support by calming overactive neural circuits, helping the brain regain equilibrium.

Through modulation of GABAergic pathways, Etizolam reduces both mental agitation and physical symptoms (e.g., trembling, muscle tension), allowing patients to relax, focus, and rest effectively.

Desired Outcomes and Clinical Benefits

• Rapid relief of acute anxiety episodes.
• Restoration of sleep continuity in anxiety-related insomnia.
• Improved daytime functioning through reduced mental fatigue.
• Relaxed musculature, easing psychosomatic tension.
• Better quality of life with restored emotional stability.

Used responsibly under professional guidance, Etizolam helps patients transition back to non-pharmacologic anxiety-management methods such as cognitive-behavioral therapy (CBT) and stress-reduction techniques.

Conclusion

Etikem-1 (Etizolam Tablets I.P. 1 mg) provides clinically recognized short-term relief from anxiety and stress-related insomnia.
By restoring GABA-mediated balance in the brain, it enables calmness, improved sleep, and better emotional regulation.

Nevertheless, Etizolam should always be used judiciously, for limited periods, and under professional supervision to minimize the risk of dependence.
Educational awareness, responsible prescribing, and adherence to therapy guidelines ensure safe and effective use of this valuable anxiolytic medication.